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This study will use an open-label design to evaluate the safety of NP101. Adult subjects who meet the enrollment criteria will be treated with NP101 (sumatriptan succinate iontophoretic transdermal patch) for acute migraine attacks over a 12 month period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NP101 | Experimental | sumatriptan iontophoretic transdermal patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NP101 | Drug | NP101 study patch four hour application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subject Self-examination of Skin Irritation | For each patch application, subjects performed a self-examination of skin irritation using a 5-point scale (0=no redness; 1=minimal skin redness; 2=moderate skin redness with sharp borders; 3=intense skin redness with or without swelling; 4=intense skin redness with blisters or broken skin). | 24 hours post patch application |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Pierce, M.D., PhD. | NuPathe Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
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The study was initiated March 2009 and completed in May 2011. Patients were enrolled from 34 investigative sites across the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | NP101 | The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Scottsdale |
| Arizona |
| United States |
| Irvine | California | United States |
| Newport Beach | California | United States |
| San Francisco | California | United States |
| Santa Monica | California | United States |
| Walnut Creek | California | United States |
| Fairfield | Connecticut | United States |
| Hallandale | Florida | United States |
| Ocala | Florida | United States |
| Sunrise | Florida | United States |
| Atlanta | Georgia | United States |
| Decatur | Georgia | United States |
| Savannah | Georgia | United States |
| Crestview Hills | Kentucky | United States |
| Ann Arbor | Michigan | United States |
| St Louis | Missouri | United States |
| Mount Vernon | New York | United States |
| Plainview | New York | United States |
| Greensboro | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Philadelphia | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Clarksville | Tennessee | United States |
| Dallas | Texas | United States |
| San Antonio | Texas | United States |
| Alexandria | Virginia | United States |
| Virginia Beach | Virginia | United States |
| Seattle | Washington | United States |
| COMPLETED |
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| NOT COMPLETED |
|
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Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months. The safety population included all subjects who applied at least one NP101 patch. Of the 514 subjects enrolled, 35 subjects did not treat for a total of 479 subjects in the safety population.
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| ID | Title | Description |
|---|---|---|
| BG000 | NP101 | The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subject Self-examination of Skin Irritation | For each patch application, subjects performed a self-examination of skin irritation using a 5-point scale (0=no redness; 1=minimal skin redness; 2=moderate skin redness with sharp borders; 3=intense skin redness with or without swelling; 4=intense skin redness with blisters or broken skin). | Per protocol, all subjects who applied at least one NP101 study patch were included in the safety population. | Posted | Mean | Standard Deviation | scores on a scale | 24 hours post patch application | Patches | Participants |
|
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|
All adverse events were collected from Screening until 30 days after the last study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NP101 | The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period. | 9 | 479 | 177 | 479 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Goiter | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Ruptured ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site discoloration | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Application site dryness | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Application site pain | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Application site paraesthesia | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Application site reaction | General disorders | MedDRA (10.0) | Systematic Assessment |
|
Per the study agreement, Investigators shall have the right to publish or present information and/or data arising from the study, provided the text of any such publication or presentation is submitted for review at least thirty days prior to submission for publication or other disclosure and NuPathe shall have the right to request the removal of any confidential information
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Pierce, MD, PhD | NuPathe Inc. | 484-567-0130 | mpierce@nupathe.com |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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